RecallRadar

FDA Device recall Z-1877-2013

Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generatio…

On 2013-08-21 the FDA classified a Class II recall of Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generatio… by Carestream Health, citing due to potential for an x-ray exposure technique change.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1877-2013
ClassificationClass II
Statusterminated
Initiated2013-06-03
Published2013-08-21
Last updated2026-09-13 11:53 UTC
CompanyCarestream Health
DistributionUS

Product

Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Reason

Due to potential for an x-ray exposure technique change.

Identifiers

code_infoCarestream DRX Evolution Systems using V5.5.410.33 MR2 Software

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1877-2013%22

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